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Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 3, 2008
Last updated: April 8, 2009
Last verified: April 2009
The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

Condition Intervention Phase
Rheumatoid Arthritis Drug: AZD5672 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • total radioactivity in plasma, whole blood, faeces and urine. [ Time Frame: Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h ]
  • Additional metabolite identification [ Time Frame: 0.5h, 3h, 6h, 12h, 24h ]

Secondary Outcome Measures:
  • general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs [ Time Frame: Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up ]

Estimated Enrollment: 4
Study Start Date: June 2008
Study Completion Date: July 2008
Arms Assigned Interventions
Experimental: 1 Drug: AZD5672
single dose 200mg aqueous solution


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body Mass index (BMI) 18-30 kg/m2, inclusive.
  • Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology & urinalysis, as judged by the investigator

Exclusion Criteria:

  • Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
  • Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
  • Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00711074

United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
Study Director: Mark Layton AstraZeneca
Principal Investigator: Raj Chetty AstraZeneca
  More Information

Responsible Party: Mark Layton, MD, MRCP(UK), MFPM, Medical Science Director, Early Development RITA, AstraZeneca Pharmaceuticals Identifier: NCT00711074     History of Changes
Other Study ID Numbers: D1710C00010
2008-001528-30 (EUdract No)
Study First Received: July 3, 2008
Last Updated: April 8, 2009

Keywords provided by AstraZeneca:
mass balance

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on August 17, 2017